ULTRACLONE ECL-01-200 CELL LINE

Cells, Animal And Human, Cultured

EARL-CLAY LABORATORIES, INC.

The following data is part of a premarket notification filed by Earl-clay Laboratories, Inc. with the FDA for Ultraclone Ecl-01-200 Cell Line.

Pre-market Notification Details

Device IDK841346
510k NumberK841346
Device Name:ULTRACLONE ECL-01-200 CELL LINE
ClassificationCells, Animal And Human, Cultured
Applicant EARL-CLAY LABORATORIES, INC. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeKIR  
CFR Regulation Number864.2280 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1984-04-02
Decision Date1984-05-11

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